Events

Recall of Invitrogen HLA AllSet+ Gold SSP

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Invitrogen Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    18824
  • Event Initiated Date
    2015-07-09
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and New Zealand.
  • Extra notes in the data
    Recalling Organisation: Life Technologies, 18-24 Botha Road, Penrose, AUCKLAND
  • Reason
    The primer mix in lane 86 (a68-03c) of specific lots of these kits was expected to produce a positive reaction with dna samples containing the a*03:20 allele. the qc comments provided with these kits have been updated to indicate the potential for a false negative reaction with the a*03:20 and like alleles. this has the potential to provide a mistype result as an a*03:01 allele.
  • Action
    Instructions for use to be updated

Device

Invitrogen HLA AllSet+ Gold SSP

Manufacturer

Invitrogen Corporation